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Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT

NCT01024595 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2011-03-01

No results posted yet for this study

Summary

The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe, well tolerated and immunogenic. The present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and cellular immune responses. The results of the present study will be key for the design of future phase II trials, particularly for the definition of the optimal schedule for boosting immunizations.

All individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, which are performed within the schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.

Conditions

  • HIV Infection

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    lead OTHER

Principal Investigators

  • Adriano Lazzarin, MD · San Raffaele Hospital - Milan, Italy

  • Aldo Di Carlo, MD · S. Gallicano Hospital- Rome, Italy

  • Pasquale Narciso, MD · I.R.C.C.S. Spallanzani Hospital, Rome

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Completion
2010-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024595 on ClinicalTrials.gov